Events

Alerta De Seguridad para URIC ACID / UIC ACID, List No. 7D76, Lot Number 95015HWOO. Registration number: 10055310819

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott-Divisão Diagnósticos.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    791
  • Fecha
    2004-04-12
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    A falsely elevated Uric Acid result may cause unnecessary treatment. There is no impact to the user's health or ability to use the product if the instructions guidelines. Increasing Uric Acid results can be identified with quality assay samples every 24 hours using the current quality control recommendations contained in the Uric Acid Reagent Application Sheet for the AEROSET Equipment. If the values ​​of the controls are high, the patient's results between the time of the high quality control test and the previous quality control test with acceptable result should be reviewed. If you have any further questions or concerns, please contact the Abbott Customer Service Center - Diagnostics Division - Phone 0800 119099
  • Causa
    When a uric acid cartridge, lot number 95015hw00 is placed in the apparatus and calibrated, samples and / or qc material can be raised to 1.1 mg / dl (0.07 moi / l) in a 24 hour period between the control trials. not all cartridges within this batch have been affected.
  • Acción
    Customer Letter was distributed to all customers who received lot number 95015HW00, recommending discontinuing the use of this lot number. This corrective action was implemented in March 2004. It is important that the following actions be taken: • Identify whether you are using or have in stock the AEROSET Uric Acid Reagents product, lot number 95015HW00. Discontinue use of batch number 95015HWOO, segregate kits from affected batches, and wait for collection of this material, by Abbott Laboratories. Will Abbott Laboratories provide replacement product for all Uric Acid kits destroyed from lot number 95015HWOO. Please complete the Response Protocol and return it to Abbott as instructed. Follow your laboratory procedures to verify the accuracy of test results and to communicate with health care providers for whom you provide services. Keep this release in the permanent archive of your laboratory. ¿If you have sent AEROSET Uric Acid Reagents, lot number 95015HW00 to another laboratory, please provide a copy of this notice to this one. During the investigation of the cause of this occurrence, it is recommended as a precautionary measure that the frequency of quality control monitoring for Uric Acid from two levels of controls (normal and abnormal) be increased every 24 hours for each 8 hours.

Device

URIC ACID / UIC ACID, List No. 7D76, Lot Number 95015HWOO. Registration number: 10055310819

Manufacturer

Abbott-Divisão Diagnósticos
  • Source
    ANVSANVISA